| Primary Device ID | 04548190101177 | 
| NIH Device Record Key | ab194834-408c-4b5e-a58e-8810513cbafe | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OMNICHROMA BLOCKER | 
| Version Model Number | 10117 | 
| Company DUNS | 693552176 | 
| Company Name | TOKUYAMA DENTAL CORPORATION | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 | 
| info@tokuyama-us.com | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04548190101177 [Primary] | 
| EBF | Material, Tooth Shade, Resin | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-10-11 | 
| Device Publish Date | 2018-09-10 | 
| 04548190101337 | Syringe Sample | 
| 04548190101313 | PLT Sample | 
| 04548190101276 | PLT | 
| 04548190101177 | SYRINGE |